Keywords

• 91374-25-3
• Ropinirole Impurity
• C16H25ClN2O4

Quick Details

• ProName: Ropinirole Impurity;91374-25-3
• CasNo: 91374-25-3
• Molecular Formula: C16H25ClN2O4
• Appearance: White to off white powder
• Application: for drug impurity for drug standards,f...
• DeliveryTime: 1-2 weeks
• PackAge: 10mg/25mg/50mg/100mg/1000mg/5000mg
• Port: Shenzhen/hongkong
• ProductionCapacity: 5000 Metric Ton/Day
• Purity: 95%+ or 98%+
• Storage: -20℃
• LimitNum: 25 Milligram
• Moisture Content: 0.1%
• Impurity: 0.1%

Superiority

Our products are mainly drug impurity reference products, drug standards, analytical chemistry, standard substances, organic chemical synthesis, chemical custom synthesis. For impurity localization, quantification, and quality control in drug development processes. Our laboratory area is more than 5000 square meters, we have more than 20 analytical instruments such as HPLC and MS/LC-MS/GC-MS, we also have TGA, IR and other testing instruments. We have the most advanced SFC preparation separation equipment. We can provide a full range of impurity reference/standard products required for drug development. Most of the impurities are synthesized through the process, there are also many items of impurities can not be obtained by synthetic means, need to be obtained through raw materials, intermediates, crude products or side reactions contained in the trace target compounds, Hubei Moke has a professional impurity preparation and separation technology team, equipped with professional SFC preparation and separation equipment. It can carry out efficient and accurate separation of impurities for complex projects, and solve the problem of impurity preparation for customers.
 

1. We integrate R&D, production and sales. A 5,000-square-meter high-standard bio-intelligent manufacturing base can ensure high quality and fast delivery of products. The professional sales team ensures that you don't need to worry about pre-sales and after-sales.

2. We focus on pharmaceutical standards, pharmaceutical intermediates, pharmaceutical impurity controls, peptide customization, our own laboratory, and undertake customized synthesis projects.

3. We offer products from gram grade to g grade, in addition, some product specifications and packaging can be customized.

4. We have been deeply engaged in the pharmaceutical field for ten years and have rich experience. At present, customers are all over the world, and have been highly recognized and trusted by customers.

5. We can provide a variety of safe ways to transport goods for you to choose.

Details

Ropinirole Impurity 13(Hydrochloride)

Product Information

• Product Code：R044013A

• English Name：Ropinirole Impurity 13(Hydrochloride)

• English Alias：2-(2-(2-(dipropylamino)ethyl)-6-nitrophenyl)acetic acid hydrochloride

• CAS No.：91374-25-3

• Molecular Formula：CHNO·HCl

• Molecular Weight：344.83（308.37 + 36.46）

Advantages

• High-Purity Standard：Confirmed by HPLC (≥99.0%), combined with NMR (1H, 13C), HRMS, and elemental analysis, accurately verifying the structure and providing a reliable basis for Ropinirole impurity detection.

• Excellent Stability：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in acetonitrile - water mixed solution within 6 months, ensuring stable and reproducible experimental data.

Applications

• Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 13 (hydrochloride) in Ropinirole API and formulations, strictly controlling impurity content to meet ICH Q3A and Q3B standards (single impurity limit ≤0.1%).

• Process Optimization Research：Monitor the formation pathway of this impurity during Ropinirole synthesis. Reduce impurity generation by over 50% by adjusting nitration reaction temperature (e.g., 5 - 10℃), optimizing reaction solvents, or reducing side reactions.

• Method Validation：Serves as a standard for developing impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.005 ng/mL) to meet the strict requirements of regulatory authorities for detection methods.

Background Description

Ropinirole, a dopamine receptor agonist, is mainly used for treating Parkinson's disease and restless legs syndrome. Impurity 13 (hydrochloride), as a process-related impurity of Ropinirole, may be generated during multi-step synthesis reactions due to incomplete nitration, alkylation reactions, or side reactions. Its nitro and dipropylamino groups may affect the drug's stability, safety, and efficacy. With the increasing strict requirements of global regulatory agencies (such as FDA and EMA) for drug impurities, the study of this impurity has become a crucial part of ensuring the quality of Ropinirole drugs and patient safety.

Research Status

• Detection Technology：UPLC-MS/MS with a C18 column (1.7μm) and 0.1% formic acid - acetonitrile gradient elution achieves separation within 4 minutes, with an LOD as low as 0.002 ng/mL, enabling highly sensitive detection of trace impurities.

• Formation Mechanism：Studies have shown that this impurity is mainly formed during the aromatic ring nitration step and subsequent alkylation reactions. It can be effectively inhibited by optimizing the reaction system pH to neutral, using inert gas protection, or replacing the synthesis route without nitration risk.

• Safety Evaluation：In vitro cytotoxicity tests show that the IC of this impurity against SH-SY5Y cells is 156.7 μM (Ropinirole IC = 12.3 μM). Although less toxic than the main drug, its content in drugs still requires strict control. Currently, long-term stability tests are being carried out to systematically monitor its degradation behavior under different humidity, light, and temperature conditions.